MAUDE Adverse Event Report: GENZYME CORPORATION SYNVISC ONE; ACID, HYALURONIC, INTRAARTICULAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Chronic Obstructive Pulmonary Disease (COPD) (2237); Reaction (2414); Angioedema (4536)

Event Date 07/23/2013

Event Type  Injury  

Event Description

Pt reports possible delayed onset allergic reaction to synvisc.She had an undocumented intolerance to egg products and had previously received synvisc without difficulty.On (b)(6) 2013 she received bilateral synvisc-one injections to her knees, on (b)(6) she reported itching and angioedema to her pcp.She was hospitalized locally and diagnosed with a copd exacerbation.She has been on chronic po steroids, but is now also on 3l of 02 by nc at all times.

• Brand Name: SYNVISC ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): GENZYME CORPORATION
• MDR Report Key: 10844212
• MDR Text Key: 216671654
• Report Number: MW5097912
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/07/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 131